Knowing how the board behaves, this wouldn't be instigated unless the chance of it working is closer to 100 than 0.
so the process for a CDx FDA approval would be similar to a drug approval? Would it only need one clinical trial vs P1/2/3? What would be the approximate time frame to an approved CDx(if successful)?
Ann: Companion Diagnostic Study Initiated with UON, page-56
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